GDUFA Research Outcomes

Ophthalmic-Otic Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the ophthalmic or otic route, including solutions, suspensions and other dosage forms.

• All(147)
• Posters(63)
• Presentations(30)
• Papers(54)

• Asymmetric Flow Field Flow Fractionation for the Characterization of Globule Size Distribution in Complex Formulations: A Cyclosporine Ophthalmic Emulsion Case

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Krishnaiah, Yellela; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert

• Computational Modeling of Drug Transport across the In Vitro Cornea

  Pak, Joseph; Chen, Zhijian; Sun, Kay; Przekwas, Andrzej; Walenga, Ross; Fan, Jianghong

• Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Products

  Zhu, Dongkai

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Zhang, Feng

• Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions

  Xu, Xiaoming

• Regulatory Perspective on MMF Applications for OIDPs, Ophthalmic Drug Products, and Drug Products Applied on the Skin

  Walenga, Ross

• Bioequivalence Assessment for Complex Ophthalmic Products

  Urtti, Arto

• GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products

  Tan, Mingliang